First Device Cleared for the Prevention of Cluster Headache

Cluster headache is considered one of the most painful conditions known to mankind. While there are drugs and devices designed to treat these sudden and excruciating headaches, there are currently no FDA-approved pharmacologic treatments for the prevention of cluster headache. There is, however a device that just received FDA clearance to do just that.

Basking Ridge, NJ-based electroCore previously had 510(k) clearance to offer its gammaCore vagus nerve stimulator as a treatment option, but FDA just cleared an expanded label for the device. The new label makes it the first product FDA cleared for the prevention of the condition.

“The FDA clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition often referred to as a suicide headache,” said electroCore CEO Frank Amato. “We are pleased that cluster headache patients now have an FDA-cleared option and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”

The company submitted data from two studies to support the new clearance. The PREVA (PREVention and Acute treatment of chronic cluster headache) pivotal study was a prospective, open-label, controlled, randomized trial that demonstrated the safety and effectiveness of gammaCore as an adjunctive therapy for the preventive treatment of cluster headache. The second study reviewed by FDA was a real-world retrospective study examining the daily clinical use of gammaCore preventively and acutely for the treatment of cluster headache.

In the PREVA study, intention-to-treat (ITT) patients who received the standard of care and gammaCore during the randomized phase had a greater reduction from the baseline (−5.9) in the number of cluster attacks per week than those receiving standard of care (−2.1), for a mean therapeutic gain of 3.9 fewer cluster attacks per week (P=0.02). In the site-adjusted model, the mean therapeutic gain was 4.2 fewer attacks per week (P=0.02).

Also, 40% of patients who received gammaCore in addition to standard of care experienced a 50% or greater reduction in weekly cluster attacks, compared to 8.3% of patients who received standard of care alone, the company noted.

In addition, there was a 57% decrease in the frequency of abortive medication use among patients who received gammaCore plus standard of care, while patients who received standard of care alone did not experience a substantial reduction in abortive medication use.

In this study, gammaCore was found to be safe and well tolerated. The incidence of adverse events was similar between patients using gammaCore plus standard of care compared to standard of care alone. The majority of the adverse events were mild and transient. The most common adverse events reported in 5% of patients or more in the gammaCore group were headache (8%), dizziness (6%), and neck pain (6%). None of the serious adverse events were considered device-related.

To prevent cluster headaches, adult patients should self-administer two gammaCore treatments daily. Each treatment consists of three consecutive two-minute stimulations. The first treatment should be applied within one hour of waking up and the second treatment should be applied at least seven to 10 hours later.

The device is a hand-held device applied to the neck that delivers a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.